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临床试验/CTRI/2020/11/029210
CTRI/2020/11/029210尚未招募1/2 期

Effectiveness Of 38% Silver Diamine Flouride In Arresting Caries With A Placebo Among Primary School Children In Hyderabad City: A Randomized Controlled Trial

H Sai Sandeep1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年11月20日最近更新:
适应症

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Caries arrest

研究概览

简要总结

Untreated dental caries is a global pandemic. Due to limited financial resources, poor access to basic oral care, and the high cost of restorative treatment, children of low-income nations have their general health, social well-being, and education opportunities affected by untreated dental caries .
  • In this context, there is interest in simple treatments to halt progress of cavities (caries lesions) after tooth decay onset .

Arresting Caries Treatment (ACT) has been proposed to manage untreated dental caries in children of disadvantaged communities.

  • Topical silver diamine fluoride  is a clear liquid that is painted on the active lesion surface in milligram amounts and arrests the lesion.
  • Cleared by the Food and Drug Administration in 2014 as a treatment for sensitive teeth and used off-label for the treatment  of cavities in the United States since 2015,12 clinical  trials outside the United States have documented caries arrest.
  • Silver diamine fluoride (SDF) treatment has been identiï¬ed as a potential solution to address the dental public health issues of untreated dental caries and insufï¬cient access to care especially among disadvantaged children.
  • The current study will assess the short term effectiveness of  38 percent SDF in arresting active caries lesions in children.
·            The Aim of this randomized controlled trial was to investigate and compare the short term effectiveness  of topically applied 38% silver diamine fluoride with a placebo in arresting caries lesions in primary school children in Hyderabad city.

Arandomized controlled trial will be carried out among 61 Primary school children inHyderabad city. The caries status of the children will be  assessed using Nyvadcriteria (1999), wherein children with score 3 of  Nvyad criteria will be included in the study. Thechildren will be randomly assigned to Active Group (n=31) and Control Group (n=30).The Active group will receive topicalapplication of 38% SDF and the control group receives topical application ofsterile water as ( placebo). Examination of caries lesions will be assessed at Baselineand after 21st day. On 21st day the number of lesions that are arrested will be evaluated based on the score 6 of Nyvad criteria.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
6.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • Children having at least one untreated cavitated active caries lesion based on Nyvad criteria.[code :3 Enamel/dentin cavity easily visible with the naked eye; surface of cavity feels soft or leathery on gentle probing ] ï‚¢ Parents who gave written informed consent .

排除标准

  • Children not willing to participate in the study ï‚¢ Presence of any gingival or perioral ulceration or stomatitis or presence of a tooth abscess.

结局指标

主要结局

Caries arrest

时间窗: 30 days

次要结局

  • Inhibits caries progression(30 Days)

研究者

发起方
H Sai Sandeep
申办方类型
Other [self]

研究点 (1)

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